Proposed Rule2023-21969
Request for Information; Coverage of Over-the-Counter Preventive Services
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 4, 2023
Issuing agencies
Treasury DepartmentInternal Revenue ServiceLabor DepartmentEmployee Benefits Security AdministrationHealth and Human Services Department
Abstract
This document is a request for information (RFI) regarding the application of the preventive services requirements under section 2713 of the Public Health Service Act (PHS Act) to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. The Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) are issuing this RFI to gather input from the public regarding the potential benefits and costs of requiring non- grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to cover OTC preventive items and services without cost sharing and without a prescription by a health care provider; seek comment on any potential challenges associated with providing such coverage; understand whether and how providing such coverage would benefit consumers; and assess any potential burden that plans and issuers would face if required to provide such coverage.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 191 (Wednesday, October 4, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Proposed Rules]
[Pages 68519-68525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21969]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-ZA31
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
[CMS-9891-NC]
RIN 0938-ZB81
Request for Information; Coverage of Over-the-Counter Preventive
Services
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This document is a request for information (RFI) regarding the
application of the preventive services requirements under section 2713
of the Public Health Service Act (PHS Act) to over-the-counter (OTC)
preventive items and services available without a prescription by a
health care provider. The Department of the Treasury, the Department of
Labor, and the Department of Health and Human Services (the
Departments) are issuing this RFI to gather input from the public
regarding the potential benefits and costs of requiring non-
grandfathered group health plans and health insurance issuers offering
non-grandfathered group or individual health insurance coverage to
cover OTC preventive items and services without cost sharing and
without a prescription by a health care provider; seek comment on any
potential challenges associated with providing such coverage;
understand whether and how providing such coverage would benefit
consumers; and assess any potential burden that plans and issuers would
face if required to provide such coverage.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. ET on December 4,
2023.
ADDRESSES: Written comments may be submitted to the address specified
below. Any comment that is submitted will be shared with the Department
of the Treasury, Internal Revenue Service, and the Department of Health
and Human Services (HHS). Commenters should not submit duplicates.
Comments will be made available to the public. Warning: Do not
include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that
you do not want publicly disclosed. All comments are posted on the
internet exactly as received and can be retrieved by most internet
search engines. No deletions, modifications, or redactions will be made
to the comments received, as they are public records. Comments may be
submitted anonymously.
In commenting, please refer to file code 1210-ZA31.
Comments must be submitted in one of the following two ways (please
choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By mail. You may mail written comments to the following address
ONLY: Office of Health Plan Standards and Compliance Assistance,
Employee Benefits Security Administration, Room N-5653, U.S. Department
of Labor, 200 Constitution Avenue NW., Washington, DC 20210, Attention:
1210-ZA31.
Always allow sufficient time for mailed comments to be received
before the close of the comment period. Because of staff and resource
limitations, the Departments cannot accept comments by facsimile (FAX)
transmission.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. The comments are posted on
the following website as soon as possible after they have been
received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on
that website to view public comments.
FOR FURTHER INFORMATION CONTACT:
Jason Sandoval, Internal Revenue Service, Department of the
Treasury, at (202) 317-5500.
Matthew Meidell or Rebecca Miller, Employee Benefits Security
Administration, Department of Labor, at (202) 693-8335.
Kei Helm, Centers for Medicare & Medicaid Services, Department of
Health and Human Services, at (667) 290-9656.
Customer Service Information:
Individuals interested in obtaining information from the Department
of Labor (DOL) concerning employment-based health coverage laws may
call the Employee Benefits Security Administration (EBSA) Toll-Free
Hotline at 1-866-444-EBSA (3272) or visit the DOL's website
(<a href="http://www.dol.gov/ebsa">www.dol.gov/ebsa</a>). In addition, information from HHS on private health
insurance coverage and on nonfederal governmental plans can be found on
the Centers for Medicare & Medicaid Services (CMS) website
(<a href="http://www.cms.gov/cciio">www.cms.gov/cciio</a>), and information on health care reform can be found
at <a href="http://www.HealthCare.gov">www.HealthCare.gov</a>.
SUPPLEMENTARY INFORMATION:
I. Background
A. Coverage of Preventive Services Under the Affordable Care Act and
Implementing Regulations
The Patient Protection and Affordable Care Act (Pub. L. 111-148)
was enacted on March 23, 2010. The Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30,
2010. These statutes are collectively known as the Affordable Care Act
(ACA). The ACA reorganized, amended, and added to the provisions of
part A of title XXVII of the PHS Act relating to group health plans and
health insurance issuers in the group and individual markets. The ACA
added section 715(a)(1) to the Employee Retirement Income Security Act
of 1974 (ERISA) and section 9815(a)(1) to the Internal Revenue Code
(Code) to incorporate the provisions of part A of title XXVII of the
PHS Act into ERISA and the Code, and to make them applicable to group
health plans and health insurance issuers providing health insurance
coverage in connection with group health plans.
[[Page 68520]]
The sections of the PHS Act incorporated into ERISA and the Code are
sections 2701 through 2728.
Section 2713 of the PHS Act, as added by section 1001 of the ACA
and incorporated into ERISA and the Code, and its implementing
regulations require that non-grandfathered group health plans and
health insurance issuers offering non-grandfathered group or individual
health insurance coverage provide coverage without imposing any cost-
sharing requirements for the following items and services:
<bullet> Evidence-based items or services that have in effect a
rating of ``A'' or ``B'' in the current recommendations of the United
States Preventive Services Task Force (USPSTF) with respect to the
individual involved, except for the recommendations of the USPSTF
regarding breast cancer screening, mammography, and prevention issued
in or around November 2009.\1\
---------------------------------------------------------------------------
\1\ The USPSTF published updated breast cancer screening
recommendations in January 2016. However, section 223 of title II of
Division H of the Consolidated Appropriations Act, 2023 (Pub. L.
117-328) requires that for purposes of PHS Act section 2713, USPSTF
recommendations relating to breast cancer screening, mammography,
and prevention issued before 2009 remain in effect until January 1,
2025.
---------------------------------------------------------------------------
<bullet> Immunizations for routine use in children, adolescents,
and adults that have in effect a recommendation from the Advisory
Committee on Immunization Practices (ACIP) of the Centers for Disease
Control and Prevention (CDC) with respect to the individual involved.
<bullet> With respect to infants, children, and adolescents,
evidence-informed preventive care and screenings provided for in
comprehensive guidelines supported by the Health Resources and Services
Administration (HRSA).
<bullet> With respect to women, such additional preventive care and
screenings not described in the USPSTF recommendations in PHS Act
section 2713(a)(1), as provided for in comprehensive guidelines
supported by HRSA.
The Departments' regulations under section 2713 of the PHS Act at
26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130 require
that plans and issuers provide coverage of recommended preventive
services generally for plan years (in the individual market, policy
years) that begin on or after September 23, 2010, or, if later, for
plan years (in the individual market, policy years) that begin on or
after the date that is one year after the date the recommendation or
guideline is issued. In addition, the regulations allow plans and
issuers to impose reasonable medical management techniques to determine
the frequency, method, treatment, or setting for coverage of a
recommended preventive health item or service, to the extent not
specified in the applicable recommendation or guideline.\2\ Moreover,
if a plan or issuer has a provider in its network that can provide a
recommended preventive service, the plan or issuer is not required to
provide coverage or waive cost sharing for the item or service when
furnished by an out-of-network provider.\3\
---------------------------------------------------------------------------
\2\ 26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), and
45 CFR 147.130(a)(4).
\3\ 26 CFR 54.9815-2713(a)(3), 29 CFR 2590.715-2713(a)(3), and
45 CFR 147.130(a)(3).
---------------------------------------------------------------------------
On March 30, 2023, the United States District Court for the
Northern District of Texas issued a final judgment in Braidwood
Management Inc. v. Becerra \4\ (Braidwood). The court held that the
USPSTF's recommendations, operating in conjunction with PHS Act section
2713(a)(1), violate the Appointments Clause of Article II of the United
States Constitution and are therefore unlawful. The Braidwood decision
vacated any and all actions taken by the Departments to implement or
enforce PHS Act section 2713(a)(1)'s preventive service coverage
requirements in response to an ``A'' or ``B'' recommendation by the
USPSTF on or after March 23, 2010, and enjoined the Departments from
implementing or enforcing PHS Act section 2713(a)(1)'s preventive
service coverage requirements in response to an ``A'' or ``B'' rating
from the USPSTF in the future.\5\ The Department of Justice filed a
notice of appeal on March 31, 2023, and a motion for a partial stay
pending appeal on April 12, 2023. On June 13, 2023, after a joint
stipulation by the parties, the United States Court of Appeals for the
Fifth Circuit granted the government's motion for a partial stay.\6\ As
a result of the partial stay, and subject to the enforcement exceptions
set forth therein for the Braidwood plaintiffs, the Departments may
continue to implement and enforce the coverage requirements for items
or services recommended with an ``A'' or ``B'' rating from the USPSTF
on or after March 23, 2010.
---------------------------------------------------------------------------
\4\ Civil Action No. 4:20-cv-00283-O (N. D. Tex. Mar. 30, 2023).
\5\ The Braidwood court also concluded that the requirement
under PHS Act section 2713(a)(1) to cover pre-exposure prophylaxis
(PrEP) with effective antiretroviral therapy for persons who are at
high risk of HIV acquisition, consistent with a June 11, 2019 USPSTF
recommendation, violated the rights of some of the plaintiffs before
the court under the Religious Freedom Restoration Act. The court
enjoined the Departments from implementing or enforcing the PrEP
coverage requirement as against these plaintiffs.
\6\ No. 23-10326 (5th Cir. May 15, 2023).
---------------------------------------------------------------------------
The Braidwood decision did not enjoin enforcement of PHS Act
section 2713 or vacate its implementing regulations and guidance
related to immunizations recommended by ACIP or preventive care and
screenings provided for in comprehensive guidelines supported by HRSA;
therefore, those requirements are not impacted by the Braidwood
decision.\7\
---------------------------------------------------------------------------
\7\ See FAQs about Affordable Care Act and Coronavirus Aid,
Relief, and Economic Security Act Implementation Part 59 (Apr. 13,
2023), available at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-59">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-59</a> and <a href="https://www.cms.gov/files/document/faqs-part-59.pdf">https://www.cms.gov/files/document/faqs-part-59.pdf</a> (FAQs Part 59).
---------------------------------------------------------------------------
B. Overview of Guidance Related to the Coverage of Recommended OTC
Preventive Services
While most recommended preventive services require a health care
provider to either provide a prescription \8\ for an item or service,
or to directly furnish a service, several preventive products are
available to consumers without the involvement of a provider (OTC
preventive products).\9\ Some examples include certain types of tobacco
cessation pharmacotherapy, which are currently recommended by the
USPSTF with an ``A'' rating for nonpregnant adults who use tobacco,\10\
and folic acid supplements, which are recommended by the USPSTF with an
``A'' rating to prevent neural tube defects for all persons planning to
or who could become pregnant.\11\ In addition, the guidelines for
women's preventive health services adopted and released by HRSA (HRSA-
supported Guidelines) include recommendations for OTC preventive
products, such as breastfeeding supplies (for example, breast pumps and
breast milk storage supplies) and certain contraceptives.\12\ As
discussed further in section I.E of this RFI, an OTC progestin-only
daily oral contraceptive was recently approved by the Food and Drug
Administration (FDA) and is expected
[[Page 68521]]
to become available soon. Additional recommended preventive products
may also become available OTC in the future.
---------------------------------------------------------------------------
\8\ This RFI's use of the term ``prescription'' encompasses an
order for an item or service, as well as a medication order by a
health care provider.
\9\ This RFI uses the term ``OTC preventive products'' to refer
to preventive items or services recommended by the applicable
recommendation or guidelines under PHS Act section 2713 and its
implementing regulations and that may be made available to an
individual without a prescription by a health care provider.
\10\ <a href="https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions">https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions</a>.
\11\ <a href="https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/folic-acid-for-the-prevention-of-neural-tube-defects-preventive-medication">https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/folic-acid-for-the-prevention-of-neural-tube-defects-preventive-medication</a>.
\12\ <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
---------------------------------------------------------------------------
Since publishing the regulations implementing PHS Act section 2713,
the Departments have received questions from interested parties
regarding coverage issues related to certain recommended preventive
services, including with respect to OTC preventive products. On
February 20, 2013, in Frequently Asked Questions (FAQs) about
Affordable Care Act Implementation Part XII, the Departments provided
guidance interpreting the statutory and regulatory requirements to
cover recommended preventive services without cost sharing to mean that
preventive products that are generally available without a
prescription, including folic acid and certain contraceptive products
(such as contraceptive sponges and spermicides), must be covered
without cost sharing only when prescribed by a health care
provider.\13\ On July 28, 2022, in FAQs Part 54, the Departments
reaffirmed that, consistent with the HRSA-supported Guidelines, plans
and issuers must cover without cost sharing FDA-approved emergency
contraception (levonorgestrel or ulipristal acetate), including OTC
products, when such products are prescribed for an individual by their
attending provider.\14\ In the same guidance, the Departments also
clarified that plans and issuers are required to cover such OTC
contraceptives without cost sharing including when they are prescribed
for advanced provision, and encouraged plans and issuers to cover OTC
emergency contraceptive products with no cost sharing when they are
purchased without a prescription by a health care provider.\15\
---------------------------------------------------------------------------
\13\ See FAQs about Affordable Care Act Implementation Part XII
(Feb. 20, 2013), Q4 and Q15, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12</a>.
\14\ See FAQs about Affordable Care Act Implementation Part 54
(July 28, 2022), Q5, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\15\ Id.
---------------------------------------------------------------------------
C. Coverage of OTC COVID-19 Diagnostic Tests Under the Families First
Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic
Security Act
Under section 6001 of the Families First Coronavirus Response Act
(FFCRA),\16\ as amended by the Coronavirus Aid, Relief, and Economic
Security Act (CARES Act),\17\ and implementing guidance,\18\ plans and
issuers were required to cover OTC COVID-19 diagnostic tests without a
prescription by a health care provider or individualized clinical
assessment, purchased on or after January 15, 2022, through the end of
the COVID-19 Public Health Emergency (PHE) declared by the Secretary of
HHS under section 319 of the PHS Act (COVID-19 PHE). OTC COVID-19
diagnostic tests covered pursuant to the FFCRA and CARES Act
requirements and implementing guidance are not OTC preventive products
subject to the preventive service requirements of section 2713 of the
PHS Act. However, interested parties' recent experiences
operationalizing coverage requirements for OTC COVID-19 diagnostic
tests without cost sharing and without a prescription by a health care
provider are relevant to the considerations included in this RFI.
---------------------------------------------------------------------------
\16\ Pub. L. 116-127.
\17\ Pub. L. 116-136.
\18\ Under section 6001(c) of the FFCRA, the Departments were
authorized to implement the requirements of section 6001 of the
FFCRA through sub-regulatory guidance, program instruction, or
otherwise. See FAQs about Families First Coronavirus Response Act
and Coronavirus Aid, Relief, and Economic Security Act
Implementation Part 42 (Apr. 11, 2020), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-42.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-42.pdf</a> and <a href="https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf">https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf</a> (FAQs Part 42); FAQs about Families
First Coronavirus Response Act and Coronavirus Aid, Relief, and
Economic Security Act Implementation Part 43 (June 23, 2020),
available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf</a> and <a href="https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf">https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf</a> (FAQs Part 43);
FAQs about Families First Coronavirus Response Act and Coronavirus
Aid, Relief, and Economic Security Act Implementation Part 44 (Feb.
26, 2021), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-44.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-44.pdf</a> and
<a href="https://www.cms.gov/files/document/faqs-part-44.pdf">https://www.cms.gov/files/document/faqs-part-44.pdf</a> (FAQs Part 44);
FAQs about Affordable Care Act Implementation Part 50, Health
Insurance Portability and Accountability Act and Coronavirus Aid,
Relief, and Economic Security Act Implementation (Oct. 4, 2021),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-50.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-50.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-50.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-50.pdf</a> (FAQs Part 50); FAQs about Affordable Care Act
Implementation Part 51, Families First Coronavirus Response Act and
Coronavirus Aid, Relief, and Economic Security Act Implementation
(Jan. 10, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf</a> (FAQs Part 51); FAQs about Families First
Coronavirus Response Act and Coronavirus Aid, Relief, and Economic
Security Act Implementation Part 52 (Feb. 4, 2022), available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-52.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-52.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-52.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-52.pdf</a> (FAQs Part 52); and FAQs about Families First
Coronavirus Response Act, Coronavirus Aid, Relief, and Economic
Security Act, and Health Insurance Portability and Accountability
Act Implementation Part 58, available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf</a> and <a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf</a>.
---------------------------------------------------------------------------
On January 10, 2022, the Departments issued FAQs Part 51, which
specified that plans and issuers were required to cover OTC COVID-19
diagnostic tests available without an order or individualized clinical
assessment by a health care provider, purchased on or after January 15,
2022 through the end of the COVID-19 PHE, and without imposing cost-
sharing requirements, prior authorization, or other medical management
requirements.\19\ FAQs Part 51 also established two enforcement safe
harbors intended to facilitate consumer access to OTC COVID-19 tests
during the COVID-19 PHE \20\ and clarified that plans and issuers were
permitted to take reasonable steps to prevent, detect, and address
fraud and abuse when providing coverage of OTC COVID-19 diagnostic
tests during the COVID-19 PHE.\21\
---------------------------------------------------------------------------
\19\ FAQs Part 51, available at https://www.dol.gov/sites/
dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/
aca-part-51.pdf and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf</a>.
\20\ The direct coverage safe harbor established in FAQs Part
51, Q2, provides that the Departments will not take enforcement
action against a plan or issuer that limited coverage of OTC COVID-
19 diagnostic tests from non-preferred pharmacies or other retailers
to no less than the actual price, or $12 per test (whichever was
lower), provided it arranged for direct coverage of OTC COVID-19
diagnostic tests through both its pharmacy network and a direct-to-
consumer shipping program. Additionally, it provides that the
Departments will not take enforcement action against any plan or
issuer that limited the number of OTC COVID-19 diagnostic tests for
each participant, beneficiary, or enrollee to no less than eight
tests per 30-day period (or per calendar month). See FAQs Part 51,
Q3.
\21\ See FAQs Part 51, Q4.
---------------------------------------------------------------------------
On February 4, 2022, the Departments published FAQs Part 52, which
further clarified the coverage requirements for OTC COVID-19 diagnostic
tests \22\ and modified the requirements for the direct coverage safe
harbor.\23\ FAQs Part 52 also clarified that plans and issuers could
address suspected fraud and abuse by limiting coverage of OTC COVID-19
diagnostic tests to those
[[Page 68522]]
purchased through established retailers (and disallow reimbursement for
tests purchased from a private individual or from a seller that uses an
online auction or resale marketplace).\24\ In addition, the guidance
clarified that the OTC COVID-19 diagnostic tests that must be covered
by plans and issuers according to FAQs Part 51 did not include COVID-19
tests that use a self-collected sample but require processing by a
laboratory or other health care provider to return results.\25\
---------------------------------------------------------------------------
\22\ FAQs Part 52, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-52.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-52.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-52.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-52.pdf</a>.
\23\ See FAQs Part 52, Q1. Under this modification, plans and
issuers were required to provide direct coverage by ensuring
participants, beneficiaries, and enrollees have adequate access to
OTC COVID-19 tests with no upfront out-of-pocket expenditure,
generally by establishing at least one direct-to-consumer shipping
mechanism and at least one in-person mechanism.
\24\ See FAQs Part 52, Q3.
\25\ See FAQs Part 52, Q4.
---------------------------------------------------------------------------
D. Executive Orders on the Affordable Care Act and Reproductive Health
On January 28, 2021, the President issued Executive Order 14009,
``Strengthening Medicaid and the Affordable Care Act'' (E.O.
14009).\26\ Section 3 of E.O. 14009 directs the Secretaries of the
Treasury, Labor, and HHS (the Secretaries) to review all existing
regulations, guidance documents, and policies to determine whether such
actions are inconsistent with protecting and strengthening Medicaid and
the ACA and making high-quality health care accessible and affordable
for every American.
---------------------------------------------------------------------------
\26\ 86 FR 7793.
---------------------------------------------------------------------------
Furthermore, the President issued Executive Order 14070,
``Continuing To Strengthen Americans' Access to Affordable, Quality
Health Coverage'' (E.O. 14070) on April 5, 2022.\27\ Section 2 of E.O.
14070 reaffirms the goals and policy of E.O. 14009 and further directs
agencies with responsibilities related to Americans' access to health
coverage to consider and pursue agency actions that improve the
comprehensiveness of coverage and protect consumers from low-quality
coverage. Accordingly, the Departments believe that improving the
access to and affordability of OTC preventive products would take
critical steps to further the goals of E.O. 14009 and E.O. 14070.
---------------------------------------------------------------------------
\27\ 87 FR 20689.
---------------------------------------------------------------------------
Similarly, following the June 24, 2022, U.S. Supreme Court decision
in Dobbs v. Jackson Women's Health Organization \28\ (Dobbs), the
President issued Executive Order 14076, ``Protecting Access to
Reproductive Healthcare Services'' (E.O. 14076) on July 8, 2022.\29\
Section 3 of E.O. 14076 requires the Secretary of HHS to identify
potential actions to ``protect and expand access to the full range of
reproductive healthcare services, including actions to enhance family
planning services such as access to emergency contraception.'' On June
23, 2023, the President issued Executive Order 14101, ``Strengthening
Access to Affordable, High-Quality Contraception and Family Planning
Services'' (E.O. 14101).\30\ Section 2 of E.O. 14101 directs the
Secretaries to consider issuing guidance to further improve Americans'
ability to access contraception, without out-of-pocket expenses, under
the ACA and to consider additional actions to promote increased access
to OTC contraception, including emergency contraception. As stated in
the preamble to the proposed rules on coverage of certain preventive
services under the ACA, it is especially critical to ensure women's
access to reproductive health care and contraceptive services without
cost sharing in light of the Supreme Court's decision in Dobbs.\31\
---------------------------------------------------------------------------
\28\ 597 U.S. _(2022).
\29\ 87 FR 42053.
\30\ 88 FR 41815.
\31\ 88 FR 7236 (Feb. 2, 2023). The references to ``women'' in
this RFI should be considered to include any individual potentially
capable of becoming pregnant, including cisgender women, transgender
men, and non-binary individuals in accordance with FAQs about
Affordable Care Act implementation Part XXVI (May 11, 2015), Q5,
available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>.
---------------------------------------------------------------------------
E. FDA Approval of Daily OTC Oral Contraceptive
On July 13, 2023, the FDA announced that it had approved a
progestin-only birth control pill as the first daily oral contraceptive
for use in the United States available without a prescription by a
health care provider.<SUP>32 33</SUP> Many interested parties have
applauded the availability of a daily OTC oral contraceptive for its
potential to improve access to affordable contraception.\34\ Studies
have shown that challenges with access and costs are among the most
common reasons cited by women for not using contraception or having
gaps in contraceptive use.\35\ One large, nationally representative
study found 29 percent of women reported encountering barriers to
obtaining or filling an initial prescription or refills of oral
contraceptive pills, specifically citing insurance coverage, getting an
appointment, not having a regular physician, and difficulty accessing a
pharmacy.\36\ Accordingly, the availability of a daily OTC oral
contraceptive without a prescription by a health care provider may
improve access and use if the product is affordable and/or covered by
insurance without cost sharing, and as a result, could reduce the
number of unintended pregnancies.\37\
---------------------------------------------------------------------------
\32\ FDA Approves First Nonprescription Daily Oral
Contraceptive, July 13, 2023, <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive">https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive</a>.
\33\ Progestin-only oral contraceptives are a product that is
already available in a prescription form and are a category of
contraceptives listed in the HRSA-supported Guidelines.
\34\ See American Medical Association. (2023). AMA Applauds FDA
Approval of OTC Birth Control. <a href="https://www.ama-assn.org/press-center/press-releases/ama-applauds-fda-approval-otc-birth-control">https://www.ama-assn.org/press-center/press-releases/ama-applauds-fda-approval-otc-birth-control</a>;
The American College of Obstetricians and Gynecologist. (2023). ACOG
Praises FDA Approval of Over-the-Counter Access to Birth Control
Pill. <a href="https://www.acog.org/news/news-releases/2023/07/acog-praises-fda-approval-of-over-the-counter-access-to-birth-control-pill">https://www.acog.org/news/news-releases/2023/07/acog-praises-fda-approval-of-over-the-counter-access-to-birth-control-pill</a>.
\35\ See Key, K., Wollum, A., Asetoyer, C., Cervantes, M.,
Lindsey, A., Rivera, R., Robinson Flint, J., Zuniga, C., Sanchez,
J., and Baum, S. (2023). Challenges accessing contraceptive care and
interest in over-the-counter oral contraceptive pill use among
Black, Indigenous, and people of color: An online cross-sectional
survey. Contraception. <a href="https://doi.org/10.1016/j.contraception.2023.109950">https://doi.org/10.1016/j.contraception.2023.109950</a>; Thompson, E.L., Galvin, A.M., Garg, A.,
Diener, A., Deckard, A., Griner, S.B., & Kline, N.S. (2023). A
socioecological perspective to contraceptive access for women
experiencing homelessness in the United States. Contraception,
<a href="https://doi.org/10.1016/j.contraception.2023.109991">https://doi.org/10.1016/j.contraception.2023.109991</a>; Bessett, D.,
Prager, J., Havard, J., Murphy, D.J., Ag[eacute]nor, M., & Foster,
A.M. (2015). Barriers to contraceptive access after health care
reform: Experiences of young adults in Massachusetts. Women's Health
Issues, <a href="https://doi.org/10.1016/j.whi.2014.11.002">https://doi.org/10.1016/j.whi.2014.11.002</a>; and Johnson, E.R.
(2022). Health care access and contraceptive use among adult women
in the United States in 2017. Contraception, 110, 30-35. <a href="https://doi.org/10.1016/j.contraception.2022.02.008">https://doi.org/10.1016/j.contraception.2022.02.008</a>.
\36\ Grindlay, K., Grossman, D. (2016). Prescription Birth
Control Access Among US Women At Risk of Unintended Pregnancy.
Journal of Women's Health. <a href="https://www.liebertpub.com/doi/10.1089/jwh.2015.5312">https://www.liebertpub.com/doi/10.1089/jwh.2015.5312</a>.
\37\ A recent study found that over 12 million adult women and
nearly two million young women aged 15-17 would be interested in
using an OTC oral contraceptive if it were free to them, but the
numbers declined to 7.1 million adult women and 760,000 young women
if the out-of-pocket cost of the contraceptive was $15. The same
study indicated that the levels of interest would translate to an
estimated eight percent decrease in unintended pregnancies
(approximately 320,000 fewer) in one year among adult women when
cost sharing was $0, and an estimated five percent decrease
(approximately 199,000 fewer unintended pregnancies) if there were a
monthly out-of-pocket cost of $15. See Wollum, Alexandra, James
Trussell, Daniel Grossman, and Kate Grindlay (2020). ``Modeling the
Impacts of Price of an Over-the-Counter Progestin-Only Pill on Use
and Unintended Pregnancy among U.S. Women.'' Women's Health Issues,
30(3): 153-160, available at <a href="https://doi.org/10.1016/j.whi.2020.01.003">https://doi.org/10.1016/j.whi.2020.01.003</a>.
---------------------------------------------------------------------------
II. Solicitation of Comments
In light of E.O. 14009, E.O. 14070, E.O. 14076, E.O. 14101, and the
FDA approval of a progestin-only oral contraceptive as the first daily
oral contraceptive available without a prescription by a health care
provider, the Departments are of the view that requiring plans and
issuers to cover, without cost sharing, OTC preventive products without
a prescription by a
[[Page 68523]]
health care provider under section 2713 of the PHS Act is an important
option to consider for expanding access to contraceptive care. The
Departments are also of the view that this option would align with the
goals of the ACA as well as the Biden-Harris Administration's policies
to expand utilization of preventive care and services by minimizing
cost barriers. However, the Departments recognize that most plans and
issuers currently do not cover OTC preventive products without a
prescription by a health care provider. Therefore, the Departments are
issuing this RFI to solicit information that will improve the
Departments' understanding of the issues related to consumer access to
OTC preventive products without cost sharing and without a prescription
by a health care provider.
The Departments are seeking to gather input from the public to
better understand the potential benefits and challenges to individuals,
plans, issuers, health care providers, retailers, and other interested
parties that may be realized by or arise in promoting greater access to
OTC preventive products, including contraceptives, without cost sharing
and without a prescription by a health care provider. For example, the
Departments would like to understand the current barriers individuals
face to receiving OTC preventive products with a prescription.
Additionally, the Departments are interested in input on any
operational challenges to plans, issuers, third-party administrators,
pharmacy benefit managers (PBMs), and retailers if plans and issuers
are required to cover, without imposing cost-sharing requirements on
the consumer, OTC preventive products purchased without a prescription
by a health care provider, including other OTC preventive products as
they might become available on the market. The Departments are also
interested in lessons learned from these interested parties'
experiences providing coverage for and facilitating the provision of
OTC COVID-19 diagnostic tests during the COVID-19 PHE. The Departments
request information on the potential obstacles and benefits that would
be associated with interpreting the preventive services coverage
requirement under PHS Act section 2713 to require coverage of OTC
preventive products without cost sharing and without a prescription by
a health care provider, and estimates of the impact of any such
potential changes, both generally and with respect to the following
specific areas:
A. Access to and Utilization of OTC Preventive Products
<bullet> What is the current cost differential for consumers
between an OTC preventive product purchased without a prescription by a
health care provider, and the same OTC preventive product (for example,
breast pumps and breastfeeding supplies) when it is prescribed? How
common is it for plans and issuers to provide coverage for OTC
preventive products without requiring a prescription by a health care
provider? Share any available measurements of utilization of coverage
for OTC preventive products when prescribed and when not prescribed by
a health care provider.
<bullet> When coverage is offered for OTC preventive products that
are prescribed by a health care provider, do cost sharing or other
aspects of coverage vary by type of OTC preventive product? For
example, are different cost-sharing requirements or medical management
techniques imposed for OTC tobacco cessation products than for OTC
breast pumps? Do coverage requirements or medical management techniques
differ across different types of OTC contraceptives, such as between
emergency contraception and condoms, or between medications and
devices? What medical management techniques do plans and issuers
commonly apply to OTC preventive products when the items are
prescribed? If plans and issuers impose quantity and/or frequency
limits or establish brand preferences for equivalent products, how do
they determine such limits and preferences?
<bullet> How does a plan's or issuer's practice of covering OTC
preventive products only when prescribed by a health care provider
affect individuals' access to OTC preventive products? What other
practices (for example, reasonable medical management techniques,
network restrictions, or formulary restrictions) are employed by plans
and issuers that restrict access to recommended preventive products
that are available OTC?
<bullet> If the Departments were to require plans and issuers to
cover OTC preventive products without cost sharing and without a
prescription by a health care provider, what would be optimal ways to
communicate these changes to help ensure that participants,
beneficiaries, and enrollees are educated about any steps they need to
take to access these products, including to get reimbursed for
purchasing OTC preventive products without a prescription by a health
care provider? Similarly, what would be optimal ways to communicate the
changes to retailers?
B. Implementation Issues
<bullet> In the event that the Departments require plans and
issuers to cover OTC preventive products without cost sharing and
without requiring a prescription by a health care provider under
section 2713 of the PHS Act, what operational challenges would plans
and issuers face in implementing the requirement? What operational
challenges would retailers (including pharmacies) face if the
requirement is implemented (for example, location of transaction,
privacy concerns, or workload at point of sale)? How would these
challenges impact participants, beneficiaries, and enrollees? How would
these challenges impact the goal of E.O. 14101 to increase access to
affordable contraception? \38\ What operational challenges may be
associated with the use of telepharmacies and mail orders both within
and across states or localities for OTC preventive products?
---------------------------------------------------------------------------
\38\ E.O. 14101. (2023).
---------------------------------------------------------------------------
<bullet> If plans and issuers were required to cover OTC preventive
products without cost sharing and without requiring a prescription by a
health care provider, how could plans and issuers ensure that
participants, beneficiaries, and enrollees who purchase OTC preventive
products do not incur out-of-pocket costs at the point of sale, or are
timely and correctly reimbursed, such as through post-purchase
reimbursement by the plan or issuer or other mechanisms? Would
utilization rates differ depending on whether the products were covered
without cost to the individual at the point of sale or were reimbursed
following purchase? Should plans and issuers be required to cover costs
associated with shipping and/or taxes for OTC preventive products? What
is the best way to eliminate out-of-pocket costs to participants,
beneficiaries, and enrollees, while ensuring that they have different
options to obtain such products (such as via direct mail and in
person)? What other issues related to consumer reimbursement would
arise if plans and issuers were required to cover OTC preventive
products without cost sharing and without a prescription by a health
care provider?
<bullet> What issues related to reimbursement to retailers and
providers would arise if plans and issuers are required to cover OTC
preventive products without cost sharing and without a prescription by
a health care provider? How might contracts between plans or issuers
and
[[Page 68524]]
PBMs, network pharmacies, or other service providers need to be
modified to cover OTC preventive products without cost sharing and
without a prescription by a health care provider? How do plans and
issuers anticipate accounting for any retail markups, discounts or
coupons, or manufacturer rebates?
<bullet> How do pharmacies or other retailers currently submit
claims to plans and issuers for OTC preventive products and are there
barriers associated with doing so? If plans and issuers were required
to cover OTC preventive products without cost sharing and without
requiring a prescription by a health care provider, would pharmacies or
other retailers be able to ensure that a consumer does not incur out-
of-pocket costs at the point of sale? If not, what barriers prevent
this, and would addressing those barriers require changes to claims
systems or additional guidance?
<bullet> If plans and issuers were required to cover OTC preventive
products without cost sharing and without requiring a prescription by a
health care provider, what types of reasonable medical management
techniques related to frequency, method, treatment, or setting would
plans and issuers consider implementing with respect to these products,
in instances where an applicable recommendation or guideline did not
specify the frequency, method, treatment, or setting for the provision
of the recommended preventive service? How would such techniques differ
or compare to strategies used currently? What additional guidance would
be necessary to help plans and issuers understand what types of medical
management techniques are considered to be reasonable when applied to
OTC preventive products?
<bullet> If plans and issuers were required to cover OTC preventive
products without cost sharing and without requiring a prescription by a
health care provider, what guardrails would plans and issuers consider
implementing to mitigate fraud, waste, and abuse?
<bullet> What operational challenges arose while plans and issuers
were required to provide OTC COVID-19 diagnostic tests without cost
sharing and without a prescription or provider involvement during the
COVID-19 PHE that were not addressed through guidance issued by the
Departments? Were there particular operational challenges experienced
by retailers? What lessons learned from those experiences could be
applied to efforts to require coverage for OTC preventive products
without cost sharing and without a prescription by a health care
provider? Would plans' and issuers' provision of direct coverage for
OTC COVID-19 diagnostic tests to participants, beneficiaries, and
enrollees by providing payments to sellers directly (without requiring
upfront payment by consumers and subsequent reimbursement by the plans
and issuers) be a model that could be used to implement an OTC coverage
requirement for preventive products? The Departments are particularly
interested in the experience of consumers, plan sponsors, retailers,
plans, issuers, PBMs, and other service providers related to techniques
that were implemented during the COVID-19 PHE to prevent, detect, and
respond to fraud, waste, and abuse related to the provision of OTC
COVID-19 diagnostic tests.
<bullet> What other strategies could the Departments implement to
increase utilization of OTC preventive products, other than, or in
addition to, requiring plans and issuers to cover such products without
cost sharing and without a prescription by a health care provider?
Should the Departments look to any specific strategies implemented by
states, localities, plans, issuers, or large employers to increase
utilization of OTC preventive products? Are there any state laws or
regulations currently in place, or expected to be proposed, that could
hinder utilization and access to OTC preventive products? If so, what
specific requirements in federal regulations could mitigate these
barriers to access? Do workplace wellness programs provide access to
OTC preventive products? If so, how do such programs manage frequency,
method, treatment, and setting to ensure effectiveness, efficiency, and
access for workers? Does access for workers differ based on their
employer's size? If so, how?
C. Health Equity
<bullet> Under current standards and requirements, do certain
populations face additional or disproportionately burdensome challenges
to accessing OTC preventive products? Do the current standards that
require coverage of only prescribed OTC preventive products without
cost sharing pose a substantial burden (for example, excess demand for
appointments) on health care providers working in, or
disproportionately serving, underserved communities? If plans and
issuers were required to cover OTC preventive products without cost
sharing and without requiring a prescription by a health care provider,
how would such a requirement improve access for these populations? For
example, is there evidence that coverage of OTC contraceptive
medications or devices without a prescription by a health care provider
would significantly impact access in ``contraceptive deserts'' (areas
with low access to family planning resources)? \39\ Could a requirement
to cover OTC preventive products without cost sharing and without a
prescription by a health care provider potentially increase the retail
prices of such products for individuals who purchase them without
insurance? If so, what are options for addressing such retail price
increases?
---------------------------------------------------------------------------
\39\ Kreitzer, R.J., Watts Smith, C., et al. (2021).
``Affordable but Inaccessible? Contraception Deserts in the US
States.'' Journal of Health Politics, Policy and Law 46(2): 277-304.
---------------------------------------------------------------------------
<bullet> Research suggests that provider bias may play a role in
limiting access to certain recommended preventive services, including,
for example, contraceptives and other family planning services, tobacco
cessation pharmacotherapy, and medication to reduce the risk of
acquiring HIV.\40\ Has permitting plans and issuers to require a
prescription to obtain coverage for OTC preventive services led to
lower utilization rates for certain recommended preventive services
among particular populations with respect to different provider types
or settings?
---------------------------------------------------------------------------
\40\ See Mann, E., Chen, A., and Johnson, C. (2022). Doctor
Knows Best? Provider Bias In the Context of Contraceptive Counseling
in the United States. Contraception. <a href="https://www.sciencedirect.com/science/article/pii/S0010782421004728">https://www.sciencedirect.com/science/article/pii/S0010782421004728</a>; Swan, T., Lefmann, T. (2023).
Health Care Provider Bias in the Appalachian Region: The Frequency
and Impact of Contraceptive Coercion. Health Services Research.
<a href="https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.14157">https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.14157</a>;
Hooper, M.W., Payne, M., & Parkinson, K.A. (2017). Tobacco cessation
pharmacotherapy use among racial/ethnic minorities in the United
States: Considerations for primary care. Family Medicine and
Community Health, <a href="https://fmch.bmj.com/content/5/3/193">https://fmch.bmj.com/content/5/3/193</a>; and Geter,
A., Herron, A.R., & Sutton, M.Y. (2018). HIV-related stigma by
healthcare providers in the United States: a systematic review. AIDS
patient care and STDs, <a href="https://doi.org/10.1089/apc.2018.0114">https://doi.org/10.1089/apc.2018.0114</a>.
---------------------------------------------------------------------------
D. Economic Impacts
<bullet> What are the current annual utilization costs and annual
operational costs to plans and issuers related to coverage of OTC
preventive products when such products are prescribed by a health care
provider? Do the costs to plans, issuers, and third-party
administrators vary for small versus large entities? If so, what are
the costs for small entities as compared to large entities?
<bullet> How would a requirement to cover OTC preventive products
without cost sharing and without a prescription by a health care
provider affect utilization costs and operational costs to plans,
issuers, plan sponsors, third-party administrators, PBMs, and
retailers? What would be the resulting premium
[[Page 68525]]
impacts, in the short- and long-term? Would utilization of OTC
preventive products significantly replace utilization of non-OTC
preventive products among participants, beneficiaries, and enrollees?
Would there be an impact on the cost of non-OTC preventive products?
What are the estimated initial and ongoing time and cost burdens on (or
savings for) plans, issuers, plan sponsors, third-party administrators,
PBMs, and retailers if plans and issuers were required to cover OTC
preventive products without cost sharing and without a prescription by
a health care provider?
<bullet> How would a requirement for plans and issuers to cover OTC
preventive products without cost sharing and without a prescription by
a health care provider affect price negotiations, pricing decisions,
market power, discount or rebate programs, and marketing practices for
these products? Would the costs to plans, issuers, third-party
administrators, PBMs, and providers vary for small versus large
entities? If so, what are the impacts for small entities as compared to
large entities? What would the net impact of these changes be on prices
for and the availability of OTC preventive products?
<bullet> To what degree would any potential increases in costs or
premiums associated with a requirement for plans and issuers to cover
OTC preventive products without cost sharing and without a prescription
by a health care provider be offset by greater access to OTC preventive
products (for example, due to improved health outcomes from greater
uptake of recommended preventive products, or fewer office visits as a
result of participants, beneficiaries, and enrollees no longer
requiring an office visit to obtain a prescription for OTC preventive
products)?
<bullet> Identify and provide estimates related to the potential
societal and economic impacts (for example, benefits, costs, and
transfers) on individuals and families, as well as on health care
providers, if OTC preventive products were required to be covered
without cost sharing and without a prescription by a health care
provider. Would these impacts vary based on region, state,
socioeconomic status, race, sex, age, insured status, or other factors?
For example, would there be potential reductions in unintended
pregnancies or maternal deaths due to participants, beneficiaries, and
enrollees no longer requiring a prescription for OTC oral
contraceptives? As another example, would there be increases in the
length of time that children are breastfed if OTC preventive products
such as breastfeeding supplies were required to be covered without cost
sharing and without a prescription by a health care provider? Would
smoking cessation rates improve with increased access to OTC tobacco
cessation products?
<bullet> Identify and provide any information regarding the
potential impact on health outcomes and quality of life of
participants, beneficiaries, and enrollees if plans and issuers were
required to cover OTC preventive products without cost sharing and
without a prescription by a health care provider.
<bullet> Identify and provide estimates related to the potential
economic impacts (short- and long-term) on health care providers,
retailers, and pharmacists if OTC preventive products were required to
be covered without cost sharing and without a prescription by a health
care provider. How would the claim processing burden for health care
providers, retailers, and pharmacists change? How would the number of
visits to health care providers, retailers, and pharmacists change?
III. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping, or third-party disclosure
requirements. However, section II of this document does contain a
general solicitation of comments in the form of an RFI. In accordance
with the implementing regulations of the Paperwork Reduction Act of
1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation
is exempt from the PRA. Facts or opinions submitted in response to
general solicitations of comments from the public, published in the
Federal Register or other publications, regardless of the form or
format thereof, provided that no person is required to supply specific
information pertaining to the commenter, other than that necessary for
self-identification, as a condition of the agency's full consideration,
are not generally considered information collections and therefore not
subject to the PRA. Consequently, there is no need for review by the
Office of Management and Budget under the authority of the PRA.
Signed at Washington DC.
Rachel D. Levy,
Associate Chief Counsel, (Employee Benefits, Exempt Organizations, and
Employment Taxes), Internal Revenue Service, Department of the
Treasury.
Signed at Washington DC.
Carol A. Weiser,
Benefits Tax Counsel, Department of the Treasury.
Signed at Washington DC.
Lisa M. Gomez,
Assistant Secretary, Employee Benefits Security Administration,
Department of Labor.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-21969 Filed 10-3-23; 8:45 am]
BILLING CODE 4120-01-P
</pre></body>
</html>Indexed from Federal Register on October 4, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.